Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

E-health Intervention in Women With Pregnancy Distress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917745
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
prof.dr. Victor J Pop, University of Tilburg

Brief Summary:
The study aims to reduce the levels of distress (depression and anxiety) during pregnancy. The study investigates the effectiveness of an eHealth pregnancy distress-reducing mindfulness training in women with pregnancy distress.

Condition or disease Intervention/treatment Phase
Pregnancy Distress Behavioral: eHealth mindfulness intervention Not Applicable

Detailed Description:

During pregnancy, women are at risk for mental health problems: up to 20% present with distress symptoms (depression and/or anxiety). Apart from the adverse effects on the woman herself, pregnancy distress negatively affects pregnancy outcome, infant health, postpartum mother-child interaction and child development.

Mindfulness-based interventions are a type of intervention that is increasingly being used to treat symptoms of stress, anxiety and depression. They are cheap and accessible to the whole population.

Current study aims to examine the effectiveness of a mindfulness training to reduce distress during pregnancy. Women who score above cut off on the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks of gestation, will be randomly allocated to the intervention or control group. Women in the intervention group will be contacted and invited to participate in the mindfulness-based intervention, which consists of 8 weeks of internet mindfulness training. The control group will receive care as usual.

The primary outcome of the study is: Does the mindfulness internet training "Ontspannen zwanger", offered during pregnancy, reduce pregnancy distress, compared to care as usual? The secondary outcome is: Does the mindfulness internet training result in better mindfulness skills?

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is part of a large longitudinal cohort study among pregnant women. The study targets a specific subgroup of pregnant women with symptoms of psychological distress (depression and anxiety). Women who score above cut off on the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks of gestation, will be randomly allocated to the intervention or control group. Women in the intervention group will be contacted and invited to participate in the mindfulness-based intervention, which consists of 8 weeks of internet mindfulness training. The control group will receive care as usual.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: E-health Intervention in Women With Pregnancy Distress: a Randomized Controlled Trial
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: eHealth mindfulness intervention group
8 weeks of internet mindfulness training
Behavioral: eHealth mindfulness intervention
The web-based intervention consists of eight sessions including psycho-education about the mechanisms of stress, coping and relaxation, especially related to pregnancy, practicing mindfulness skills (i.e. mindful breathing, mindful moving, observing and letting-go of thoughts and emotions with a non-judgmental attitude), sharing experiences, and doing home assignments. The sessions have been developed specifically for pregnant women and acknowledge pregnancy-related distress. An online coach will review questions and home assignments of the participants. Women will start the training at 16 weeks gestation.
Other Name: Ontspannen zwanger

No Intervention: Control group
Care as usual



Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention). ]
    Measured by the 10-item Edinburgh Depression Scale (EDS). The EDS is the most widely used self-rating scale to assess depressive symptoms in the perinatal period. It consists of ten items and three sub-scales: anhedonia, anxiety and depression. The questionnaire has been validated in Dutch pregnant women. The EDS total score ranges from 0 to 30, with higher scores indicating more depressive symptoms.


Secondary Outcome Measures :
  1. Negative Affect [ Time Frame: Difference between the intervention group en the control group, measured at 28 weeks (after the intervention). ]
    Measured by a subscale of the Tilburg Pregnancy Distress Scale (TPDS): Negative Affect, which consists of 10 items. The TPDS has been validated among Dutch pregnant women and it is a reliable measure to assess pregnancy-related emotional distress. The total score ranges from 0 to 30, with higher scores indicating more emotional distress symptoms.


Other Outcome Measures:
  1. Mindfulness skills [ Time Frame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention). ]
    Measured by three facets of the Five Facet Mindfulness Questionnaire Short Form (FFMQ-3-SF): acting with awareness, non-judging and non-reacting, which consists of 15 items. The validity of the measure is established and indices of internal reliability were found to be adequate. The total score ranges from 0 to 60, with higher scores indicating better mindfulness skills.

  2. Rumination [ Time Frame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention). ]
    Measured by the Rumination-Reflection Questionnaire (RRQ), which consists of 12 items and is a validated and reliable instrument. The score ranges from 0 to 48, with higher scores indicating more rumination.

  3. Self compassion [ Time Frame: Measured in the intervention group, the difference between 16 weeks (before the intervention) and 28 weeks (after the intervention). ]
    Measured by the Self Compassion Scale Short Form (SCS-SF), which consists of 12 items, and is a validated and reliable measure. The total score ranges from 0 to 72, with higher scores indicating higher self compassion.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women (18+y) who have their first antenatal visit < 12 weeks;
  • Score above cut off on the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks of gestation;
  • Dutch-speaking or understanding Dutch.

Exclusion Criteria:

  • Gemelli pregnancy (or higher order pregnancy);
  • Known endocrine disorder before pregnancy (diabetes-I, Rheumatoid arthritis);
  • Severe psychiatric disease (schizophrenia, borderline or bipolar disorder);
  • HIV;
  • Drug or alcohol addiction problems;
  • Any other disease resulting in treatment with drugs that are potentially adverse for the fetus and need careful follow-up during pregnancy;
  • No access to the internet.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917745


Contacts
Layout table for location contacts
Contact: Victor JM Pop, Prof. dr. 0031134662175 v.j.m.pop@tilburguniversity.edu

Locations
Layout table for location information
Netherlands
Tilburg University Recruiting
Tilburg, Netherlands
Contact: Victor JM Pop, Prof. dr.         
Sponsors and Collaborators
University of Tilburg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: prof.dr. Victor J Pop, Principal Investigator, University of Tilburg
ClinicalTrials.gov Identifier: NCT03917745    
Other Study ID Numbers: 50-54300-98-244
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by prof.dr. Victor J Pop, University of Tilburg:
anxiety
depression
eHealth
mindfulness
pregnancy distress